Clinical trials are one component of human research, which provides the benefits of comparing the effectiveness of current patient care and providing access to innovative treatments. WA Health is working with national bodies, State hospitals and the WA Health Translation Network to implement initiatives to improve Australia's capability and capacity to conduct clinical trials.
To find further information on the Australian Clinical Trials Initiatives visit the AustralianClinicalTrials.gov.au website.
The members of the Clinical Trials Jurisdictional Working Group (CTJWG) have produced an interim Second Activity Report on Clinical Trials in Australian Public Health Institutions 2015-16 which captures the majority of new clinical trials approved in public health organisations in five jurisdictions in Australia. It includes the time taken for each of the two approvals needed for every clinical trial in Australia - ethics and research governance.
In line with the requirements of the National Health and Medical Research Council's (NHMRC) National Statement on Ethical Conduct in Human Research, 2007 to minimise duplication of ethical review, WA Health implemented the:
In 2013, WA Health implemented the WA Health Single Ethical Review scheme for intra-jurisdictional (within WA) single-centre or multi-centre research. Under this scheme all multi-centre research projects conducted at sites under the control of WA Health or involving participants, their tissue or data accessed through WA Health must be ethically and scientifically reviewed only once, by a Lead WA Health Human Research Ethics Committee (HREC). The exception is those projects that require additional specialist HREC review.
WA Health sites must accept the ethical and scientific review undertaken by a Lead WA Health HREC as sufficient review for the purposes of the multi-centre projects conducted at sites under their control.
Find further information on the process in the WA Health Research Governance and Single Ethical Review Standard Operating Procedures (OD 0446/13).
Find contact details for Lead HRECs.
Under this scheme, either the WA Health Ethics Application Form (WAHEAF) or Human Research Ethics Application (HREA) accompanied by the Western Australian Specific Module (WASM) can be used for an ethics application. For additional information refer to Research Ethics and the WA Health Research Authorisation Monitoring Form Guidelines.
The National Mutual Acceptance (NMA) scheme has been implemented in public health organisations within the Australian Capital Territory, New South Wales, Queensland, South Australia, Western Australia and Victoria. WA Health participation commenced from 31 August 2017. Under the NMA, all multi-centre research projects being conducted at public health organisations within the participating jurisdictions must be ethically and scientifically reviewed only once by a NHMRC Certified Lead HREC participating in the NMA. The exception is those research projects that require additional specialist review (refer to NMA documents below for further information).
Please Note: The NMA does not currently support single ethical and scientific review of multi-jurisdictional projects involving data linkage and access to state-wide data collections in WA and NSW. For WA refer to the WASM, for other jurisdictions, please contact the local jurisdictional research office for further advice on requirements and processes. Contacts are available in the Fact Sheet August 2017.
WA Health sites must accept the ethical and scientific review undertaken by a NHMRC Certified Lead HREC participating in the NMA as sufficient review for the purposes of the multi-centre projects conducted at sites under their control.
Find further information on the process in the WA Health NMA Guidelines December 2017 and WA Health Research Governance and Single Ethical Review Standard Operating Procedures (OD 0446/13).
The Department of Health's WA Health National Mutual Acceptance September 2017 presentation gives an overview of the scheme and information on how to submit an ethics application to either a WA Health or non-WA Health NMA Lead HREC.
Under the NMA scheme, the HREA must be used for all ethics applications.
If ethical review is by a WA HREC: the Coordinating Principal Investigator (CPI) should complete the HREA via the NHMRC website and uploaded to the RGS website as a pdf supporting document. It should be submitted with the WASM via RGS.
If ethical review is by a ACT, NSW, QLD, SA or VIC HREC: the CPI should complete and submit the HREA via the Online Forms website.
For information on all WA Health ethics forms refer to the Research Ethics webpage and WA Health Research Authorisation Monitoring Form Guidelines.
If the sites from these jurisdictions are involved in the project, these supporting documents must be submitted to the reviewing HREC (irrespective of the committee's location).
If ethical review is by a WA HREC: the WASM must be completed and submitted via RGS with the HREA supporting document.
If ethical review is by an ACT, NSW, QLD, SA or VIC HREC: the WASM must be completed within RGS, printed and submitted via Online Forms to the reviewing HREC. Once the WASM is approved by the reviewing HREC, it can be submitted via RGS (along with the approval letter, approved supporting documents and pdf of the HREA) to a WA Health Research Governance (RG) Office to accompany the governance application.
Find further information on the NMA application process in the WA Health NMA Guidelines December 2017.
CPIs that are submitting an application to a reviewing HREC outside of WA for a project involving WA sites, must always complete the WASM in RGS, as it is tied to the HREA.
If the ethical review is performed in ACT, NSW, QLD, SA or VIC, the non-WA CPI must register with RGS and 'Create a New Project'. Once the project is created the CPI (or CPI Delegate) must complete the Sites, Members, Declarations (as applicable) and Project Details tabs before creating and completing a WASM in the Forms & Documents tab. Refer to Quick Start Guide for New Users for quick step-by-step guidance regarding this process.
Do not 'submit' the completed WASM at this point (as the reviewing HREC may require changes). Print the WASM as a pdf to your PC and uploaded it as a supporting document to the HREA in Online Forms.
The PI (and site Project Members) must use the RGS to create, complete and submit the relevant governance forms to the WA Health RG Office affiliated with the WA Health site:
If the ethical approval is performed outside WA, the non-WA CPI should use RGS to submit the approved WASM (in the 'active' section of Forms & Documents tab) along with the uploaded approved HREA (pdf) and supporting documents to the relevant WA RG Office. This can occur independently of the PI creating and submitting the SSA or Access Request forms.
The CPI must use Online Forms to create a SSA form for each participating site in ACT, NSW, QLD, SA or VIC.
If the ethical review is performed in WA: the CPI (WA) should use Online Forms to create a Minimal Dataset Form (MDF), upload copy of HREA and supporting documents, create SSA(s) and transfer each SSA to the site Principal Investigator.
If the ethical review is performed in ACT, NSW, QLD, SA or VIC: the non-WA CPI should use Online Forms process to create the SSAs and transfer them to the PIs as usual practice.
NMA is not retrospective; projects that already have ethics approval must remain under their approving HREC and apply the conditions of approval that were applied by the reviewing HREC. However, in accordance with the Standard Principles for Operation additional sites from newly joined jurisdictions may be added to projects approved under the NMA process, by way of amendments.
If your project is already going through the ethical review process with a WA Health HREC and it is being conducted across Australia, then it should continue to approval with that HREC.
If the project is changing to the NMA scheme and has already been created in RGS but not yet submitted to a WA Health HREC, there may be changes that need to be made. If the CPI is outside WA, the CPI for the project will need to be changed, refer to Help Wiki 'Change the CPI'. The Internal & External HREC in section 1 of Project Details may have to be changed, refer to Help Wiki Complete Project Header for National Mutual Acceptance (NMA). In section 2 of Project Details, question 3 the 'Type of ethical review' should be updated to 'National Mutual Acceptance single ethical review'.
Research involving individuals who lack decision-making capacity presents a number of ethical and legal challenges for researchers and HRECs. Specific information relevant to WA is available on the RGS Help WA Specific Information Public Pages.
These challenges are compounded for multi-jurisdictional studies as each jurisdiction has different requirements. The NHMRC has produced a Report on the relevant State, Territory and National laws that relate to consent and guardianship requirements for human research, including clinical trials. A series of Australian guides/checklists to consent and guardianship laws are available for use by HRECs and researchers.
The NHMRC Guide to WA Laws Factsheet provides information for WA HRECs and researchers. The Factsheet does not constitute legal advice and researchers and institutions in particular should discuss their specific proposal with their own legal advisors.
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